1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
Lyophilization Services of New England, Inc. dba PCI Pharma Services — FDA 483 Findings
Inspectors Daniel L Zheng · Armen H Youssoufian · Ogechi C Nna and 2 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
4Equipment and facility
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
5Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Similar findings at other companies
GRM selected findings from the same type of public document whose wording is close to a finding in this document. One per company.
- Hybrid Pharma LLC2026-08-27 · US FDASimilar to finding 3 Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity…
- Huangshi Hygenic Material Medicine Co.2024-08-30 · US FDASimilar to finding 4 Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
- BSP Pharmaceuticals S.p.A.2022-03-31 · US FDASimilar to finding 5 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- Phoenix Innovative Healthcare Manufactures Private Limited2024-09-27 · US FDASimilar to finding 5 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations…
- Glenmark Pharmaceuticals Inc USA2022-05-19 · US FDASimilar to finding 1 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
A record as of the US FDA document published on 2026-11-13. Check the agency's announcements for any later corrective action, and rely on the original text. Translation and classification are machine-made.